中药新药药学研究的思考  

Considerations of pharmaceutical research for new drugs of Chinese materia medica

作　　者：赵巍 马秀璟 屠鹏飞[2] ZHAO Wei;MA Xiu-jing;TU Peng-fei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;School of Pharmaceutical Sciences,Peking University,Beijing 100191,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]北京大学药学院,北京100191

出　　处：《中草药》2019年第23期5872-5875,共4页Chinese Traditional and Herbal Drugs

摘　　要：为加快药品审评审批速度,国家药品监督管理局颁布一系列鼓励药品创新的政策,申请临床试验实行60日默示许可、建立沟通交流机制等制度。通过分析调整后的中药新药审评思路,充分认识药学阶段性研究的必要性,对中药注册申报不同阶段药学研究的侧重点从药材来源、工艺设计、质量标准建立等方面进行阐述,从而加快中药审评审批进程,为中药新药注册申报提供参考。A series of policies to encourage innovative drug were issued and implemented in opinions of speeding up new drug review and approval by National Medical Products Administration,including application for drug clinical trials on 60 days of implied permission and the communication mechanism.In this article,we analyzed the adjustment of new drug review,and explained the necessity and difference in pharmaceutical research and development of Chinese materia medica(CMM),and illuminated the main problems and emphases in CMM pharmaceutical research in aspects of source of medicinal materials,production process,quality research and standards,expecting to provide reference for speeding up new drug review and benefit drug applicants.

关 键 词：中药新药 中药注册申报 药学阶段性研究 药材来源 工艺设计 质量标准 

分 类 号：R288[医药卫生—中药学]